PBAC's latest decision on Axitinib: Recommended with restriction (2014). Considered for Second-line treatment of stage IV clear cell variant renal cell carcinoma (RCC) in patients with progressive disease following first-line tyrosine kinase inhibitor treatment.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2013
Submissions
2
2013 → 2014
Eligible population
Adults with stage IV clear cell variant renal cell carcinoma with progressive disease according to RECIST following first-line treatment with a tyrosine kinase inhibitor, with WHO performance status of 2 or less.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
PFS
Pivotal trial size
723 patients
Key trials
AXIS, RECORD-1
Comparator
everolimus
Economic model
Not modelled
ICER note
ICER not stated in the PSD. Economic modelling was not conducted as the submission was based on indirect comparison of PFS and OS outcomes.
ICER (historical)
$45k/QALY–$75k/QALY in an earlier submission (2013) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Nov 2013: Not recommended · Not applicable — ICER $75k/QALY
Nov 2014: Recommended with restriction · Authority Required